BEUDAMED
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    INTRABLOCK BIOBALL HIP SYSTEM (IBS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOERSTER SPONGE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896093164·FOERSTER SPONGE FORCEPS STRAIGHT SERRATED TIP

    KING SEPTEMS

    FDA Adverse Event
    Malfunction ·KING SEPTEMS·Product code LMA·November 1, 2012

    SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ORTHODONTIC FLOWABLE BRACKET ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973295·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970690·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970676·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970645·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970621·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970638·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970683·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970652·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970669·

    SCRDRIVERSHAFT T25 F/URS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·May 22, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    36CM PERM CATH KIT X5

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LFJ·June 10, 2011

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiationfree attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·August 23, 2017

    Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiationfree attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·May 11, 2017